A Two Week Dosing Study to Determine the Safety and Antiviral Activity of LCQ908 in Hepatitis C Patients

Hepatitis C Clinical Trial

Official title:

Double-blind, Randomized, Placebo-controlled, Multi-center Trial, to Determine the Safety and Antiviral Effect of 14 Days of LCQ908 Monotherapy in Hepatitis C Infected Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01387958
• Other study ID #: CLCQ908A2214
• Status: Terminated
• Phase: Phase 2
• First received: July 1, 2011
• Last updated: May 6, 2012
• Start date: July 2011
• Est. completion date: February 2012

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medsafe
• Study type: Interventional

Clinical Trial Summary

This is a proof of concept study, designed to look at the safety and antiviral activity of LCQ908 in hepatitis C infected patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Written informed consent.

• Male and female subjects 18 to 65 years of age with hepatitis C infections (genotypes 1, 2 or 3).

• No prior therapy or inadequate response to therapy for hepatitis C.

• Weight at least 50 kg and body mass index (BMI) within 18 - 35 kg/m2.

Exclusion Criteria:

• Use of other investigational drugs within at least 30 days of enrollment

• Women of child-bearing potential.

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• LCQ908

• Placebo

Locations

Country	Name	City	State
New Zealand	Novartis Investigative Site	Auckland
New Zealand	Novartis Investigative Site	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Change in hepatitis C viral load as assessed by PCR		2 weeks	No
Secondary	Measure: Safety assessments will include vital signs, electrocardiograms (ECG), liver function tests, and adverse events.		28 days	Yes
Secondary	Measure: LCQ908 concentrations in the blood		over 21 days	No